BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC TREK CORONARY DILATATION CATHETER

    MDR report key: 2830728 · Received November 13, 2012

    Report

    Report Number
    2024168-2012-07160
    Event Type
    Malfunction
    Date Received
    November 13, 2012
    Date of Event
    October 19, 2012
    Report Date
    October 19, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K110134
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED THE BALLOON RUPTURE WAS CONFIRMED. THE REPORTED DIFFICULTY TO REMOVE COULD NOT BE REPLICATED AS THE RETURNED DEVICE WAS NOT RETURNED IN A CONDITION IN WHICH THE TEST COULD BE PERFORMED. BASED ON ANALYSIS OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES FOR THE LOT. THE RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FOR THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE (IFU) STATES THE BALLOON PRESSURE SHOULD NOT EXCEED THE RATED BURST PRESSURE (RBP). BASED ON THE INFORMATION REVIEWED, THERE IS NO EVIDENCE TO INDICATE THE PRESENCE OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE 90% STENOSED, DISTAL, MID, AND PROXIMAL RIGHT CORONARY ARTERY (RCA). AFTER IMPLANTING STENTS IN THE DISTAL, MID, AND PROXIMAL RCA, A 4.0 X 15 MM NC TREK BALLOON CATHETER WAS USED FOR POST-DILATATION. THE BALLOON WAS PRESSURIZED 3 TIMES TO 24 ATMOSPHERES; HOWEVER, WHEN REMOVING THE CATHETER, IT COULD NOT BE WITHDRAWN INTO THE 5F GUIDING CATHETER. THE BALLOON CATHETER AND THE GUIDING CATHETER WERE REMOVED AS A SINGLE UNIT. OUTSIDE THE PATIENT, IT WAS CONFIRMED THE BALLOON HAD RUPTURED. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NC TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 1121562

    Patients

    Seq Age Sex Outcome Treatment
    1